MX4040 Intrauterine Pressure Monitoring Kit
FDA 510(k)Class II (US FDA 510(k))
by Medex, Inc.
Identifiers
- 510(k) Number
- K860101 FDA 510(k)
- FDA Product Code
- KXO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2700 FDA 510(k)
- Regulation Number
- 884.2700 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MX4040 Intrauterine Pressure Monitoring Kit is a Class II medical device classified as a pressure monitor, intrauterine. It is designed to detect and measure intrauterine and amniotic fluid pressure using a transcervically placed catheter, enabling real-time assessment of uterine contractions during labor. This includes monitoring the intensity, duration, and frequency of contractions to support obstetric management.
This kit is intended for single-use in clinical settings such as labor and delivery units. It is supplied sterile and requires no additional sterilization. The device is regulated under FDA 510(k) clearance (K860101) and falls under the product code KXO, adhering to 21 CFR 884.2700. No MRI safety information is specified, and sizes or additional accessories are not detailed in the regulatory submission.
Frequently asked questions
What clinical scenarios is the MX4040 Intrauterine Pressure Monitoring Kit primarily used for during labor and delivery?
The MX4040 Intrauterine Pressure Monitoring Kit is designed to measure intrauterine and amniotic fluid pressure in real-time during labor. It helps clinicians assess the intensity, duration, and frequency of uterine contractions, which is particularly useful for monitoring high-risk pregnancies, managing abnormal labor patterns, or evaluating fetal well-being when standard external monitoring may be insufficient.
Is the MX4040 Intrauterine Pressure Monitoring Kit intended for reuse, or is it meant to be used only once per patient?
The MX4040 Intrauterine Pressure Monitoring Kit is explicitly labeled for single-use only in clinical settings. It is supplied sterile and does not require additional sterilization, ensuring patient safety and compliance with infection control protocols.
How is the MX4040 Intrauterine Pressure Monitoring Kit regulated in the U.S., and what does that mean for purchasing or using it?
The MX4040 Intrauterine Pressure Monitoring Kit is classified as a Class II medical device under FDA 510(k) clearance (K860101) and falls under product code KXO (21 CFR 884.2700). This means it has undergone FDA review for safety and effectiveness, and its use is governed by U.S. medical device regulations. Hospitals and clinicians can rely on its regulatory status as evidence of compliance with U.S. standards for intrauterine pressure monitoring.
Does the MX4040 Intrauterine Pressure Monitoring Kit come with any additional accessories or specific sizes, or is it a standalone system?
The provided regulatory data does not specify additional accessories or size variations for the MX4040 Intrauterine Pressure Monitoring Kit. It is described as a transcervically placed catheter system for measuring intrauterine pressure, implying it is a complete kit for its intended purpose. Clinicians should confirm with Medex, Inc. if specialized accessories (e.g., connectors, adapters) are required for their specific monitoring setup.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MX4040 INTRAUTERINE PRESSURE MONITORING KIT (K860101) — FDA 510(k ..., MX4040 INTRAUTERINE PRESSURE MONITORING KIT 510 (k)… - FDA.report, PDF K860101 - Mx4040 Intrauterine Pressure Monitoring Kit, fda.innolitics.com, Class 2 Device Recall Medex Closed Blood Sampling kits and pressure ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K860101 | Class II | Active |
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Manufacturer
- Manufacturer
- Medex, Inc.
Sources (1)
- FDA 510(k) K860101 24 fields · synced Oct 6, 2026